Caraco Brand 0.25 mg Digoxin Tablets Recalled due to Size Variability
A S Medication Solutions, LLC, a drug repackage company, has announced that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being recalled to the consumer level.
The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure.
Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.
Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.
Product Identification
Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”
NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)
Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.
MAY-12-09-30-08: Caraco Brand 0.25 mg Digoxin Tablets Recalled due to Size Variability [FDA: DIGOXIN 0.25 MG TABLETS RECALLED]
Legal Help
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